(55 days)
OsteoPore TCP is indicated only for filling bone voids or defects of the skeletal system (such as the extremities, spine and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoPore TCP should be gently packed into the defect/void without under-filling or over-filling. OsteoPore TCP is a Jonne graft substitute that resorbs and is replaced with bone during the healing process.
The OSTEOPORE TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.
The provided text does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. The document is a 510(k) summary for a bone void filler (OsteoPore TCP), focusing on its substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods. The document primarily establishes the device's regulatory classification, intended use, and its equivalence to an already approved product based on design, material, and function.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.